00A: Full-Day Workshop on Human Research Protections

Level

All Levels

Human Research Reviews:  Mastering the Process

This workshop is a collaboration between the HHS Office for Human Research Protections (OHRP) and the NIH Office of Extramural Research (OER).
Note: You may register for this workshop without attending the 2-day NIH Regional Seminar. 

Full Day Workshop: 8:30 a.m. – 4:30 p.m.

This workshop aims to provide participants with the necessary information to successfully navigate their NIH grant applications and research protocols through human research protections review. It will provide attendees with a general understanding of the federal regulations and policies on protecting human subjects in research and how to apply them to research protocols, as well as practical advice on how to master the human research review process. Updates on the regulations and NIH policies will be discussed as appropriate.

Target Audience

This workshop is primarily intended for investigators applying for NIH funding to conduct human subjects research or submitting human research protocols for IRB review. This workshop is also suitable for new IRB administrators and reviewers as a basic training on the federal policies for human research protections.

Learning Objectives

Upon completing the workshop, participants will be able to:

  • recognize whether a proposed activity is human subjects research according to the regulations, and explain how to apply the regulations when appropriate;
  • describe the key ethical principles to be considered when conducting responsible human subjects research;
  • understand the NIH policies on human subjects research protections, the related NIH peer review process, and the expectations for completing the Protection of Human Subjects section in the NIH grant application;
  • describe the investigator’s role in protecting human subjects in research and the key features of the informed consent process;
  • describe the role of the IRB in reviewing and approving research, and the criteria it must consider; and
  • understand how to navigate the IRB process.

Workshop Agenda

8:30 – 8:45 a.m. Introduction and Logistics

8:45 – 10:15 a.m. A Review of the Common Rule and Its Application – OHRP (90 min, OHRP)

This presentation will begin with a brief overview of the history and ethical principles underlying the Federal regulations for human research protections. It will explain the role of the HHS Office for Human Research Protections (OHRP) in protecting human subjects and recent revisions to the Common Rule. The bulk of the presentation will focus on how to determine whether research activities fall within the scope of the regulations and how the Common Rule revisions will impact these determinations.

10:15 – 10:30 a.m. Break (15 min)

10:30 – 11:40 p.m. Preparing the NIH Protection of Human Subjects section and Understanding How It’s Reviewed – NIH (70 min)

This presentation will walk participants through preparing the Protection of Human Subjects section of an NIH grant application. It will provide an overview of the grant review process and discuss the criteria reviewers use to determine if the application has included adequate protections for human subjects.

11:40– 12:00 p.m. Overview of NIH’s New Policies – NIH (20 min)

This session will provide a brief overview of new policies related to human subjects research being implemented by NIH, including the policy on single IRB review of cooperative research and policies relevant to clinical trials.

12:00 – 1:30 p.m. Lunch (90 min.)

1:30 – 3:00 p.m. Mastering the Informed Consent Process – OHRP (90 min, OHRP)

This interactive session will examine the regulatory requirements for informed consent and investigators’ responsibilities in the contexts of the current and revised Common Rule, with an emphasis on understanding “spirit” of the regulations and how they support an effective informed consent process.

3:00 – 3:15 p.m. Break (15 min.)

3:15 – 4:15 p.m. What Investigators Should Know About IRB Review – OHRP (60 min, OHRP)

This presentation will discuss the role of institutional review boards (IRBs) in human research protection and the regulatory criteria IRB’s use when reviewing research proposals. The goal of this interactive session is to explain how to prepare a research proposal that addresses the regulatory requirements and help investigators understand their responsibilities with respect to IRB review. Regulatory discussion will cover both the current and revised Common Rule.

4:15 – 4:30 p.m. Q & A/ Closing Remarks – all speakers (15 min.)

This short session will provide participants with the opportunity to ask remaining questions or clarify earlier points.

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